Expired Study
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New York, New York 10021


Purpose:

RATIONALE: Drugs used in chemotherapy, such as epothilone D, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well epothilone D works in treating patients with stage IIIB or stage IV non-small cell lung cancer that has not responded to platinum-based chemotherapy.


Study summary:

OBJECTIVES: Primary - Determine the antitumor activity of epothilone D, in terms of confirmed objective response rate, in patients with stage IIIB or IV non-small cell lung cancer who failed prior initial platinum-containing chemotherapy. Secondary - Determine the safety of this drug in these patients. - Determine the response duration in patients who achieve complete response or partial response, time to tumor progression, and survival in patients treated with this drug. - Compare the power associated with the estimated treatment effect of this drug in these patients vs standard treatment. - Correlate efficacy and safety with plasma concentrations of this drug and its major metabolites in these patients. OUTLINE: This is a multicenter, open-label study. Patients receive epothilone D IV over 90 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 33-85 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) - Stage IIIB* or IV disease NOTE: *Due to malignant pleural effusion or supraclavicular lymph node involvement only - Previously treated with maximally feasible surgical resection and/or radiotherapy for initial disease - Failed 1 prior platinum-containing chemotherapy regimen for advanced or metastatic disease due to disease progression or treatment toxicity - At least 1 site of unidimensionally measurable disease by physical exam or radiography - No known CNS metastases or leptomeningeal metastases requiring corticosteroids PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 Life expectancy - More than 3 months Hematopoietic - Absolute neutrophil count ≥ 1,500/mm^3 - Hemoglobin ≥ 8 g/dL - Platelet count ≥ 75,000/mm^3 Hepatic - AST ≤ 2.5 times upper limit of normal (ULN) (5 times ULN for patients with hepatic metastases) - Alkaline phosphatase ≤ 5 times ULN - Bilirubin ≤ 1.8 mg/dL Renal - Creatinine ≤ 2.0 mg/dL Cardiovascular - No New York Heart Association class III or IV congestive heart failure - No personal or family history of congenital long QT syndrome - No QTc interval > 450 msec (males) or > 470 msec (females) by ECG Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No preexisting neuropathy ≥ grade 2 - No other malignancy within the past 5 years except for the following: - Cured basal cell skin cancer - Carcinoma in situ of the cervix or urinary bladder - Stage T1 or T2 prostate cancer with prostate-specific antigen < 2 ng/mL - No hypersensitivity reaction ≥ grade 3 to prior Cremophor-containing therapy - No infection requiring parenteral or oral anti-infective therapy - No weight loss of ≥ 10% within the past 3 months - No altered mental status or psychiatric illness that would preclude giving informed consent - No other medical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent granulocyte-macrophage colony-stimulating factor (sargramostim [GM-CSF]) - No concurrent routine prophylactic granulocyte colony-stimulating factor (filgrastim [G-CSF]) Chemotherapy - See Disease Characteristics - At least 3 weeks since prior chemotherapy and recovered Endocrine therapy - See Disease Characteristics Radiotherapy - See Disease Characteristics - At least 3 weeks since prior radiotherapy and recovered Surgery - See Disease Characteristics - At least 3 weeks since prior surgery and recovered Other - Prior adjuvant or neoadjuvant therapy allowed - Prior radiosensitizers allowed - At least 2 weeks since prior gefitinib - More than 3 weeks since prior investigational agents (therapeutic or diagnostic) - No other concurrent investigational agents - No other concurrent anticancer treatment


NCT ID:

NCT00081107


Primary Contact:

Principal Investigator
Naiyer Rizvi, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 16, 2017

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